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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 05/30/2014
Event Type  Malfunction  
Event Description

The unused generator has been returned to the manufacturer where analysis is currently underway.

 
Event Description

It was reported that during lead replacement surgery on (b)(6) 2014 due to high impedance, the vns patient¿s replacement generator was interrogated and showed pulse disablement. The generator was not used and a different generator was implanted. The pulse disablement is believed to be due to electrocautery that was used during the procedure. The unused generator has not been returned to date. The high impedance was reported in manufacturer report # 1644487-2014-01214.

 
Event Description

On (b)(4) 2014 product analysis was completed on the explanted generator. Review of the data indicated that the pulse disabled byte was set to a value that represents a vbat

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3892636
Report Number1644487-2014-01582
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/30/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/24/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2016
Device MODEL Number103
Device LOT Number202820
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/19/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/29/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/12/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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